Trial Outcomes & Findings for Diaphragm Ultrasound Vs Transpulmonary Pressure To Set PEEP in ARDS (NCT NCT02463773)

Results Overview

This is a proof of concept study that investigates the degree of dorsal and ventral diaphragmatic excursion with bedside ultrasound during PEEP titration. Optimal PEEP management was guided by an esophageal probe calculating transthoracic pulmonary pressure. Each patient underwent a series of PEEP titrations for which data was recorded on diaphragm excursion (mm) and esophageal pressure (cmH2O). Diaphragm excursion (mm) was measured at the ventral and dorsal side using anatomic m-mode with bedside ultrasound. Esophageal pressure was measured using an esophageal probe which was placed at the bedside.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

one year

Results posted on

2022-05-17

Participant Flow

Participant milestones

Participant milestones
Measure	Ultrasound Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission. Ultrasound: Diaphragmatic excursion ultrasound assessment
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diaphragm Ultrasound Vs Transpulmonary Pressure To Set PEEP in ARDS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrasound n=14 Participants Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission. Ultrasound: Diaphragmatic excursion ultrasound assessment
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants

PRIMARY outcome

Timeframe: one year

Population: We verify that all participants met the criteria and a total of 14 were enrolled.

This is a proof of concept study that investigates the degree of dorsal and ventral diaphragmatic excursion with bedside ultrasound during PEEP titration. Optimal PEEP management was guided by an esophageal probe calculating transthoracic pulmonary pressure. Each patient underwent a series of PEEP titrations for which data was recorded on diaphragm excursion (mm) and esophageal pressure (cmH2O). Diaphragm excursion (mm) was measured at the ventral and dorsal side using anatomic m-mode with bedside ultrasound. Esophageal pressure was measured using an esophageal probe which was placed at the bedside.

Outcome measures

Outcome measures
Measure	Ultrasound n=14 Participants Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission. Ultrasound: Diaphragmatic excursion ultrasound assessment
Feasibility	14 Participants

Adverse Events

Ultrasound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roy Cho, MD

University of Minnesota

Phone: 612-626-2637

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place